Manager, Clinical Operations

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Job Description

The Manager, Clinical Operations (Specimen Management) is responsible for team management, clinical study management of multiple studies. This role may be a subject matter authority for group or platform of assigned clinical studies including the planning, implementation, project management and completion of clinical studies conducted by Medical Affairs or Contract Research Organizations (CRO). The Manager, Clinical Operations, also serves as mentor and manager of Clinical Project Managers and/or Senior Clinical Project Managers.

This role serves as the overall team lead for multiple studies of high complexity from protocol development through study conduct and closeout in compliance with Good Clinical Practices, and all Global, National and Local Regulations. The Manager, Clinical Operations, provides strategic direction for clinical programs, collaborates with cross‑functional team leaders on business requests, and evaluates or develops early plans and concepts for optimal study execution.

• Lead and develop a team of Clinical Project Managers, ensuring study teams consistently meet or exceed the timelines, quality standards and deliverables.
• Establish team objectives, performance expectations, and development plans for Clinical Project Managers and monitor performance, ensuring alignment with Clinical Operations goals and organizational priorities.
• Provide management oversight and reviews of study‑related and essential study start‑up documents to ensure quality, compliance and timely execution (e.g., Clinical Protocols, Informed Consent forms, Monitoring Plan, Clinical Product Management Plan, Clinical Safety Management Plan, Case Report Form [CRFs], CRF Completion Guidelines and other relevant documents).
• Oversee and optimize allocation of study management resources.
• Coach, mentor, and support the professional growth and career development of Clinical Project Managers and Senior Clinical Project Managers.
• Provide oversight for the development and review of protocols, clinical study reports and other clinical study deliverables as applicable.
• Lead continuous improvement initiatives that enhance study execution efficiency, quality, and compliance.
• Support internal audits by leading and/or contributing to audit investigations, conducting root cause analyses, and overseeing the development and implementation of corrective and preventive action (CAPA) plans to ensure compliance and continuous improvement within the Clinical Project Manager team.
• Foster and maintain strong collaborative relationships with sites/PIs, internal stakeholders, other study‑related vendors, including CROs.
• Apply advanced project management principles and methodologies to maintain integrated project plans (e.g., scope, time/schedule, cost/material and resources, quality, communication/escalation, risk, etc.), while facilitating key cross‑functional discussions and decision‑making.
• Monitor, evaluate and report key performance indicators, study milestones and operational metrics from the Clinical Project Manager team.
• Proactively identify, assess and mitigate study execution and compliance risks, ensuring appropriate escalation and resolutions are implemented.
• Adapt study management deliverables based on study scale and complexity.
• Create bold…